New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:

08/17/2007

Trade Name:

Provigil

Generic Name or Proper Name (*):

modafinil

Indications Studied:

Narcolepsy

Label Changes Summary:

* Modafinil is not approved for use in pediatric patients for any indication * Safety and effectiveness were not demonstrated in a controlled 6-week study in 165 pediatric patients 5-17 years with narcolepsy * Serious rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with the use of modafinil * In the controlled and open-label clinical studies, treatment emergent adverse events of the psychiatric and nervous system included Tourettes syndrome, insomnia, hostility, increased cataplexy, increased hypnagogic hallucinations and suicidal ideation * Information on safety, AEs and clinical study